Precision Exercise Therapeutics (PET-pilot)

Not Applicable

Recruiting

• Conditions: Overweight; Healthy
• Interventions: Other: High intensity interval training; Other: Continuous aerobic exercise; Other: Resistance training

• Registration Number: NCT05718089
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

The aim of this randomized cross-over study is to collect information for the design of a precision exercise therapy cohort that will predict what modality of physical activity a physically inactive individual with overweight should perform to increase insulin sensitivity given their unique biology, environment, and context.

Detailed Description

This pilot study is needed prior to launching precision therapeutics programs, with the purpose to decrease the risk of research waste, increase the reliability of the experimental tests and estimate adequate sample size.

25 participants will be recruited to undergo three sets of experiments. An experiment consists of one exercise bout followed by an assessment of whole-body insulin sensitivity (measured from a oral glucose tolerance test) 1 and 2 days following the completion of the exercise bout yielding 19 study days of 3 hours each across 7 weeks, including the baseline measurement. The exercise modalities include 1) continuous aerobic exercise, 2) high intensity exercise and 3) resistance exercise training. A set consists of test-retest of the same experiment.

The objectives of this pilot study are

1. to assess the longevity of the increased whole-body insulin sensitivity in the days following different exercise modalities

2. To estimate the intra-individual differences of different exercise modalities on whole-body insulin sensitivity the days following the last exercise bout

3. To assess the fidelity of the test- and exercise protocols

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-29
• Study First Posted: 2023-02-08
• Study Start: 2023-03-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• BMI>25
• Age> 40 years
• Inactivity, defined as < 1,5 hours of structured physical activity pr. week at moderate intensity and cycling < 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)

Exclusion Criteria

• • HbA1c>53 mmol/mol

  • Uncontrolled hypertension
  • Uncontrolled hyperlipidemia,
  • Known hyperthyroid disease
  • Endocrine disorders causing obesity
  • Known autoimmune disease
  • Unstable cardiovascular disease
  • Glucose lowering medications except for low dose metformin (=<1000 mg/day)
  • Current treatment with anti-inflammatory medication, unless pain killers without prescription
  • No participation in other research intervention studies
  • Pregnancy/considering pregnancy within the study period
  • Conditions countering exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High intensity interval training	High intensity interval training	The training consists of 10 minutes of warm up followed by 25 minutes of high intensity interval training (5 bouts of 4 min at \>85% HRmax interspaced by 4 minutes of low intensity training) and finally a 4 min cool-down.
Continuous aerobic exercise	Continuous aerobic exercise	The participants will complete a 10-min warm up, followed by 40 min of continuous aerobic exercise at an individualized intensity at 64-76% of the maximal heart rate HRmax on a bicycle ergometer/walking.
Resistance training	Resistance training	The participants will complete moderate intensity whole-body resistance training. This will consist of 4 sets with 4 exercises (leg press, chest press, back row, leg extension in appropriate machines) with a brief warm-up prior to each exercise. Each set will be interspersed by 2-min breaks. Each set (including breaks) will thus equate to 2.5 min. Intensity will be set a 12-repetition max (RM, i.e., can repeated no more than 12 times) or 10 repetitions with 1-2 repetitions in reserve (i.e., 10 repetitions where failure would occur within 1-2 more repetitions).

Primary Outcome Measures

Name	Time	Method
24 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	6 weeks	Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 24 hours following the exercise bout
24 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	6 weeks	Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose insulin sensitivity index) from baseline to 24 hours following the exercise bout

Secondary Outcome Measures

Name	Time	Method
Variation in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	6 weeks	Mean and standard deviations of intra- and inter-individual differences in whole-body insulin sensitivity (Matsuda index) in response to different exercise modalities 1 and 2 days following the previous exercise bout.
Variation in gastric emptying	6 weeks	Mean and standard deviations of intra- and inter-individual differences in post-prandial (from an OGTT) gastric empyting, measured by paracetamol, in response to different exercise modalities 1 and 2 days following the previous exercise bout.
48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	6 weeks	Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose sensitivity index) from baseline to 48 hours following the exercise bout
24 to 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	6 weeks	Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose sensitivity index) from 24 hours to 48 hours following the exercise bout
Variation in fasting and postprandial urinary C-peptide	6 weeks	Mean and standard deviations of intra- and inter-individual differences in fasting and post-prandial (derived from an OGTT) urinary C-peptide in response to different exercise modalities 1 and 2 days following the previous exercise bout.
Variation in insulin sensitivity (Oral glucose sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	6 weeks	Mean and standard deviations of intra- and inter-individual differences in whole-body insulin sensitivity (Oral glucose sensitivity index) in response to different exercise modalities 1 and 2 days following the previous exercise bout.
Variation in fasting and postprandial glucose	6 weeks	Mean and standard deviations of intra- and inter-individual differences in fasting and post-prandial (derived from an OGTT) plasma glucose in response to different exercise modalities 1 and 2 days following the previous exercise bout.
Variation in fasting and postprandial plasma C-peptide	6 weeks	Mean and standard deviations of intra- and inter-individual differences in fasting and post-prandial (derived from an OGTT) plasma C-peptide in response to different exercise modalities 1 and 2 days following the previous exercise bout.
24 to 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	6 weeks	Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from 24 hours to 48 hours following the exercise bout
Variation in fasting and postprandial insulin	6 weeks	Mean and standard deviations of intra- and inter-individual differences in fasting and post-prandial (derived from an OGTT) plasma insulin in response to different exercise modalities 1 and 2 days following the previous exercise bout.
Assessment of free living physical activity	6 weeks	Mean and standard deviations of intra- and inter-individual differences in free living physical activity (measured by accelerometers) in response to different exercise modalities
Assessment of continuous glucose	6 weeks	Mean and standard deviations of intra- and inter-individual differences in continuous glucose (measured by continuous glucose monitors) in response to different exercise modalities
Assessment of psychosocial stress	6 weeks	Mean and standard deviations of intra- and inter-individual differences in psychosocial stress (measured by questionnaires) in response to different exercise modalities
Feasibility of the test and training protocols	6 weeks	Feasibility will be assessed using a qualitative questionnaires. Subject domains include e.g. participant satisfaction with 1) time spend on test- and training, 2) the recruitment process, 3) communication regarding participation and 4) the written information about participation, 5) acceptability of the tests.
48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	6 weeks	Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 48 hours following the exercise bout

Trial Locations

Locations (1)

Center for Aktiv Sundhed - Rigshospitalet, Denmark (CFAS); 🇩🇰 Copenhagen, Østerbro, Denmark